Like most industries, the health care sector is grappling with the uses of artificial intelligence (AI) and what AI means for the future. At the same time, many health care companies already have integrated algorithms and AI...more
2/13/2024
/ Algorithms ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Medicare Advantage ,
Natural Language Processing ,
Popular ,
Qui Tam ,
Whistleblowers
Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase...more
10/4/2023
/ Advisory Opinions ,
Billing ,
Carve Out Provisions ,
Clinical Laboratories ,
Competition ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
OIG ,
Physicians ,
Risk Management
For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more
4/29/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Department of the Interior ,
Enforcement Actions ,
Enforcement Authority ,
FBI ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Medical Billing Codes ,
Medicare ,
OIG ,
Provider Relief Fund ,
Telemedicine ,
USPS
STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION -
FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more
2/11/2022
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
Nursing Homes ,
Pharmaceutical Industry ,
Pharmacies ,
Qui Tam ,
Telehealth
During a recent panel discussion hosted virtually by the American Bar Association, attorneys from the Department of Justice (DOJ) and certain U.S. Attorneys’ Offices known for health care fraud enforcement provided valuable...more
As our readers know, we have long been closely watching False Claims Act (FCA) cases across the country alleging the submission of false claims based on the lack of medical necessity, particularly as a possible circuit split...more
Last Friday, the Department of Justice (DOJ) announced another increase to civil monetary penalties assessed under the False Claims Act (FCA), among other statutes.
DOJ made these adjustments to account for inflation, in...more
As many of our readers know, as a result of the public health emergency caused by COVID-19, effective March 1, 2020, the U.S. Department of Health and Human Services (“HHS”) issued blanket waivers of its authority under...more
On Monday, the U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited and closely watched decision in United States v. AseraCare Inc.. The court ruled that a claim cannot be deemed false under the False Claims...more
9/12/2019
/ Defense Strategies ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospice ,
Medical Necessity ,
Motion for Summary Judgment ,
Physicians ,
Qui Tam ,
Relators ,
Remand ,
Sua Sponte
WHAT’S INSIDE -
Who Decides How Bankruptcy Laws Are Applied?
PROMESA: An Experiment Doomed to Fail -
The Role of Alter Ego in Restructuring -
SPECIAL FRAUD SECTION -
Don’t Depend on a Handshake -
Health...more
4/25/2019
/ Department of Justice (DOJ) ,
False Claims Act (FCA) ,
FRCP 9(b) ,
Government Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Motion to Dismiss ,
Petition for Writ of Certiorari ,
Qui Tam ,
Relators
As many of our readers know, we have been closely following the Polukoff False Claims Act (FCA) qui tam case, which is based on allegations that certain heart procedures performed by a cardiologist were not medically...more
2/8/2019
/ Appointments Clause ,
Article II ,
Denial of Rehearing ,
Failure to Comply ,
False Claims Act (FCA) ,
FRCP 9(b) ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Petition for Writ of Certiorari ,
Split of Authority ,
Whistleblowers
In a three-sentence order issued on October 29th, the Tenth Circuit Court of Appeals declined to grant a Request for Rehearing in the closely watched Polukoff case. One of the questions raised in the Request was whether, by...more
The all-too-common story of a healthcare company declaring bankruptcy in the face of aggressive Medicare recoupment actions before the company even has a hearing before an Administrative Law Judge (ALJ) may get a new ending –...more
Last week, the U.S. Attorney’s Office for the District of Massachusetts announced that it had entered into an agreement with a Massachusetts-based medical device manufacturer to settle allegations that the Company had...more
As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices. Earlier this month, the...more
2/20/2018
/ Controlled Substances Act ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians
Earlier this week, the Office of Inspector General for the Department of Health and Human Services (“OIG”) posted its fiscal year (“FY”) 2016 data about Medicaid Fraud Control Units (“MFCUs”) across the country....more
Last month, the U.S. District Court for the District of Utah joined the AseraCare court and others in finding that a relator cannot successfully allege violations of the False Claims Act (“FCA”) based on a purported lack of...more
Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more
7/27/2016
/ Acquittals ,
CEOs ,
Corporate Executives ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Felonies ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Care Providers ,
Medical Devices ,
Misdemeanors ,
Off-Label Promotion ,
Personal Liability ,
Yates Memorandum
On May 6th, we posted about the possibility that the Department of Justice (“DOJ”) might dramatically increase False Claims Act (“FCA”) penalties after the Railroad Retirement Board (“RRB”) nearly doubled the per-claim...more
The already enormous per-claim penalties under the federal False Claims Act (“FCA”) may nearly double by August 1, 2016, ratcheting up the stakes of FCA cases for health care providers, pharmaceutical and medical device...more
Trends & Analysis -
Since our last Qui Tam Update, we have identified 39 health-related False Claims Act (“FCA”) qui tam cases that have been unsealed. Of those cases...more
9/22/2015
/ ACOs ,
Anti-Kickback Statute ,
Controlled Substances ,
False Billing ,
False Claims Act (FCA) ,
Falsified Documents ,
Former Employee ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Internal Controls ,
Medicaid ,
Medicare ,
Medicare Shared Savings Program ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
Relators ,
Retaliation ,
Settlement ,
State False Claims Acts ,
Stipulations ,
Third-Party Service Provider ,
TRICARE ,
Whistleblowers ,
Wrongful Termination
Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees...more
8/4/2015
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Leased Employees ,
Management Agreements ,
Medicaid ,
Medicare ,
OIG ,
Patient Referrals
On Thursday April 16th, President Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”). Pub.L. 114-10. In two previous posts, we discussed MACRA’s repeal of the Sustainable Growth Rate...more